Regulatory Associate, Surgery

UT Southwestern Medical Center • Dallas, TX

2d • Onsite

About The Position

The Regulatory Associate for the Department of Surgery's Surgical Partners in Research (SPAR) office supports the department's regulatory and compliance activities by coordinating, maintaining, and monitoring regulatory documentation and Institutional Review Board (IRB) submissions in accordance with applicable federal, state, institutional, and sponsor requirements. This role collaborates closely with research sponsors, clinical research coordinators, and principal investigators to support regulatory processes across various studies such as medical device and drug studies. The ideal candidate demonstrates a strong interest in clinical research and regulatory affairs, with a particular enthusiasm for surgical, medical device, and pharmaceutical research. Prior clinical research experience is highly valued. The Regulatory Associate plays a key role in supporting regulatory readiness, study lifecycle activities, and adherence to quality and compliance standards.

Requirements

• Bachelor's Degree or equivalent
• 2 years of related experience
• May consider experience and education in lieu of requirements.

Nice To Haves

• Prior clinical research experience is highly valued.
• Strong interest in clinical research and regulatory affairs.
• Particular enthusiasm for surgical, medical device, and pharmaceutical research.

Responsibilities

• Review study protocols, informed consent documents, response to stipulations, and other study-related documentation, to assure conformance with all applicable requirements.
• Provide working supervision, training, and guidance to lower-level Regulatory Assistants. Assign tasks and set work priorities. Review work for accuracy.
• Administer expedited and exempt research review processes, including, but not limited to: intake of protocols and assessment of review level (with referral to full IRB/IACUC, when applicable); regular one-on-one meetings with IRB/IACUC Chairs for final determinations; drafting correspondence to investigators regarding IRB/IACUC determinations.
• Provide consultation and technical assistance to investigators and study personnel regarding requirements for IRB/IACUC submissions, performance of studies, and documentation of compliance. Serve as an information resource to the campus about human subject protection and/or animal care and use.
• Participate in development of and/or updates to IRB/IACUC guidance, office procedures/business processes, related forms, database improvements, and other quality assurance activities.
• Perform other duties as assigned.

Benefits

• PPO medical plan, available day one at no cost for full-time employee-only coverage
• 100%25 coverage for preventive healthcare-no copay
• Paid Time Off, available day one
• Retirement Programs through the Teacher Retirement System of Texas (TRS)
• Paid Parental Leave Benefit
• Wellness programs
• Tuition Reimbursement
• Public Service Loan Forgiveness (PSLF) Qualified Employer

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level